News

“The world is not waiting for us,” Ursula von der Leyen, the European Commission president told journalists on 29 January as she introduced new proposals to improve the competitive position of European industry. The Commission president outlined three goals for the coming year. They include providing incentives for new companies, especially in artificial intelligence; advancing clean energy; and expanding commercial partnerships with companies and countries across the globe. The measures for companies include incentives for generating risk capital. 

A radiopharmaceutical which is being developed for patients with neuroendocrine tumours, a rare form of cancer, has delivered positive data from a Phase 3 trial paving the way for a possible regulatory submission this year, according to the developer ITM Isotope Technologies Munich SE. The therapy, ITM-11, achieved statistically significant progression- free survival for patients compared with everolimus, a small molecule immunosuppressant that was first approved by the US Food and Drug Administration in 2009.

Two oligonucleotide drugs are to enter the clinic this year for the treatment of Huntington’s disease and epilepsy using a technology that directly targets the brain and spinal cord. The developer, Atalanta Therapeutics Inc of Boston, US, announced the prospective trials on 28 January alongside the close of a $97 million Series B financing round which will bring the candidate therapies up to the clinical proof-of-concept stage. The financing was co-led by the private equity group EQT Life Sciences and Sanofi Ventures.

The Alzheimer’s disease drug, Leqembi (lecanemab), has been approved in the US for a new dosing schedule enabling patients to continue taking it after 18 months of treatment. The new maintenance indication will enable dosing once every four weeks using an intravenous administration. It will take effect after the 18-month initiation phase of bi-weekly dosing finishes. Leqembi has been approved for patients with mild cognitive impairment or mild dementia, also known as early Alzheimer’s disease.

Netherlands-based Forbion has raised €164.5 million for a fund that supports projects in the food, agriculture, materials and environmental sectors. Founded in late 2023, the BioEconomy Fund I represents a different branch of the biological sciences than Forbion’s traditional pharmaceutical holdings. The goal is to support environmentally-friendly businesses that can shape future behaviour and consumption.

Shanghai, China-based YolTech Therapeutics Co Ltd has started clinical development of an in-vivo gene editing product for beta-thalassaemia, an inherited blood disorder that is estimated to involve one in every 100,000 patients worldwide. The disease affects the production of normal haemoglobin, a protein in red blood cells that carries oxygen to tissues in the body.

AstraZeneca Plc is to invest $570 million in infrastructure in Canada with the goal of executing more than 210 global clinical studies in the country. Announced on 23 January, the investment accelerates a move to place Canada on its map as a centre for global clinical development activity. It follows the UK company’s acquisition in 2024 of Fusion Pharmaceuticals Inc, a Canadian biopharmaceutical company developing alpha-particle radiotherapeutics for cancer. The acquisition of Fusion was completed last year for C$3 billion ($2.09 billion).

A communications pause reportedly ordered by the Trump administration to the US federal health agencies and affecting their communications to the public and external partners had not been formally notified to the EU effective 24 January. The pause took effect on 21 January and is expected to continue through 1 February, according to the Washington Post, which obtained information about the pause from two internal memos. The pause was not publically announced. 

Citing the importance of the World Health Organization in maintaining global healthcare, a spokesperson for the European Commission said on 21 January that dialogue with the Trump Administration is the best way forward in addressing any shortcomings of the agency. “We need common solutions for common problems. We need to engage together,” she commented.

TILT Biotherapeutics Ltd is a Finnish company developing oncolytic virus therapies for cancer. Its lead product, TILT-123 is poised to enter Phase 2 studies in patients with ovarian cancer after having demonstrated that it is safe and able to elicit responses from patients. In an interview, Victor Cervera-Carrascón, the company’s head of business development, gave three reasons why he thought the time is optimal for the biotech industry to pay more attention to oncolytic therapies.